Biothrax Side Effects

Note: This page contains information about the side effects of anthrax vaccine adsorbed. Some of the dosage forms included on this document may not apply to the brand name Biothrax.

Not all side effects for Biothrax may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to anthrax vaccine adsorbed: suspension

In addition to its needed effects, some unwanted effects may be caused by anthrax vaccine adsorbed (the active ingredient contained in Biothrax). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking anthrax vaccine adsorbed, check with your doctor or nurse immediately:

More common

Pain, redness, tenderness, or limited movement of the arm where the injection is given

Less common

Swollen, painful, or tender lymph glands in the neck, armpit, or groin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

redness of the skin

shakiness in the legs, arms, hands, or feet

shortness of breath

skin rash

sores, ulcers, or white spots in the mouth or on the lips

trembling or shaking of the hands or feet

unusual tiredness or weakness

Some of the side effects that can occur with anthrax vaccine adsorbed may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

For Healthcare Professionals

Applies to anthrax vaccine adsorbed: subcutaneous suspension

Local

Local side effects are reported most commonly and have included tenderness, erythema, subcutaneous nodule, induration, warmth, local pruritus, arm motion limitation, and edema. Local reactions tended to occur more often in females.[Ref]

Severe local reactions defined as edema or induration >120 mm diameter , marked arm motion limitation, or marked axillary node tenderness have been reported in 0.15% of vaccinees (n=15,907). Moderate local reactions defined as edema or induration 30 mm to 120 mm have been reported in 0.94%. Mild reactions have been reported in 8.63%.[Ref]

Gastrointestinal

Gastrointestinal side effects have included anorexia, nausea, and vomiting.[Ref]

Musculoskeletal

Musculoskeletal side effects have included transient myalgia and arthralgia. Inflammatory arthritis has rarely been reported; however, causality has not been established.[Ref]

Other

Systemic reactions have included transient headache, fever, fatigue, malaise, and chills. In post-licensure studies, systemic reactions were reported in 5% to 35% of vaccinees and occurred more often in women.[Ref]

Respiratory

Respiratory side effects have included transient respiratory difficulty. Asthma has been reported rarely; however, causality has not been established.[Ref]

Hypersensitivity

One case of delayed hypersensitivity has been reported. A vaccinee developed lesions by day 3 after the first dose, diffuse hives by day 17 (3 days after the second dose), and swollen hands, face, and feet, and discomfort swallowing by day 18.[Ref]

Hypersensitivity reactions have included delayed hypersensitivity and anaphylaxis.[Ref]

Nervous system

Nervous system side effects have included dizziness. Seizure, tremors, aseptic meningitis, encephalitis, transverse myelitis, cerebrovascular accident, facial palsy, hearing and visual disorders, Guillain-Barre Syndrome, and multiple sclerosis have been reported rarely; however, causality has not been established.[Ref]

Dermatologic

Dermatologic side effects have included pruritus. Cysts, pemphigus vulgaris, and cellulitis have rarely been reported; however, causality has not been established.[Ref]

Other

Other side effects have rarely included sepsis, systemic lupus erythematosus, polyarteritis nodosa, and spontaneous abortion; however, causality has not been established.[Ref]

Hematologic

Hematologic side effects have rarely included aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia; however, causality has not been established.[Ref]

Psychiatric

Psychiatric side effects have rarely included mental status changes, psychiatric disorders, and mood-cognition disorders; however, causality has not been established.[Ref]

Cardiovascular

Cardiovascular side effects have rarely included myocarditis, cardiomyopathy, atrial fibrillation, syncope, endocarditis, angioedema, and collagen vascular disease; however, causality has not been established.[Ref]

Hepatic

Hepatic side effects have rarely included liver abscess; however, causality has not been established.[Ref]

Renal

Renal side effects have rarely included glomerulonephritis and renal failure; however, causality has not been established.[Ref]

Immunologic

Immunologic side effects have rarely included immune deficiency; however, causality has not been established.[Ref]

Consumer resources

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